Wearable electronic device for enhancing visualization during insertion of an invasive device

ABSTRACT

A wearable electronic device configured to be worn by a user while performing an invasive procedure for enhancing visualization of desired anatomical structures is provided. The wearable electronic device includes: a housing; at least one imaging sensor associated with the housing; and a visual display integrally formed with or associated with the housing. The device is configured to acquire an image of an invasive access site of a patient with the at least one imaging sensor, process the image to determine a location of a desired anatomical structure, and display a virtual trace of the location to the user via the visual display.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional Application61/933,049 entitled “Wearable Electronic Device for EnhancingVisualization During Insertion of a Vascular Access Device” filed Jan.29, 2014, the entire disclosure of which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to systems and methods for enhancingvisualization of an invasive procedure requiring procedural guidance,such as providing enhanced visualization of a vein during an insertionprocedure using a vascular access device, and, more particularly, tosystems and methods that operate in a hands-free manner using a wearableelectronic device.

Description of Related Art

Blood sampling is a common health care procedure involving thewithdrawal of at least a drop of blood from a patient. Blood samples arecommonly taken from hospitalized, homecare, and emergency room patientseither by finger stick, heel stick, or venipuncture. Once collected,blood samples may be analyzed to obtain medically useful informationincluding chemical composition, hematology, coagulation, etc.

Similarly, fluid delivery to a patient is accomplished using a varietyof vascular access devices, including syringes, auto-injectors, peninjectors, catheters, and infusion devices. In medical settings, aclinician or technician performs an injection by inserting a needle intoa patient's vein. A therapeutic agent is directly or passively providedto the patient through the needle. For example, the medical technicianmay inject fluid by pressing a piston rod and plunger through a syringebarrel to expel fluid therefrom. Alternatively, a therapeutic agent maybe provided passively from an IV bag through an infusion set.

Prior to performing a fluid sampling or fluid delivery procedure, theclinician or technician is responsible for obtaining any needed medicalinstruments and devices. The clinician or technician may also beresponsible for performing an initial examination of the patient bychecking temperature, heart rate, or breathing. The clinician ortechnician may review notes in the patient's medical chart or otherprinted instructions to ensure that these initial steps are performedcorrectly and that any necessary equipment has been obtained.Alternatively, the technician may scan bar codes or other identifyingindicia on the obtained equipment to document that certain items arebeing used. The medical professional then obtains the fluid sample orperforms the fluid injection. After the sample is collected or fluid isinjected, the clinician or technician may be required to provideappropriate documentation that the procedure has been completed. Forexample, the clinician or technician may write notes in a patient'smedical chart, including the time the procedure was completed, adescription of the procedure that was performed, and notes concerningany abnormal or unexpected occurrences. Furthermore, in the case ofobtaining fluid samples, the medical professional may be responsible forclosing or sealing the collected sample with tamper-proof seals toprevent the sample from being compromised prior to testing. Thetechnician or clinician may be responsible for verifying the seal by,for example, signing his or her name or initials on a breakable labelcovering the seal.

In many medical facilities, these preparation, confirmation, anddocumentation activities are performed manually by the clinician ortechnician either as the medical procedure is being performed or afterthe procedure is completed. For example, the clinician or technician maybe responsible for manually labeling each collected fluid sample withidentifying information about the patient before transferring the samplefor testing. Similarly, the clinician or technician may be responsiblefor manually documenting the type of fluid injected to a patient in thepatient's chart. The medical professional may also be expected todocument the date and time that the procedure was performed. In somecircumstances, the clinician or technician is provided with electronicdocumenting means, such as a computer, laptop computer, table PC, smartphone, or similar easily transportable computing device. However, thetechnician or clinician is still responsible for manually enteringinformation to the electronic device. Alternatively, data entrytechnicians may be responsible for electronically entering informationabout the procedure that was performed based on notes taken by theclinician or technician. Furthermore, many larger medical facilitiesrely on electronic patient databases for electronically storing patientinformation. However, even such electronic databases still requiremanual entry of data either by the clinician or technician, or laterdata entry based on contemporaneous notes taken by the clinician ortechnician.

The numerous manual steps required before, during, and after fluidsampling or fluid delivery procedures introduce opportunities for usererror. User errors may lead to incomplete or incorrect procedures beingperformed or may result in lost patient data. For example, the clinicianor technician may inject an incorrect fluid volume, incorrect fluid typeor concentration, or may not obtain a sufficient volume of fluid samplefor the tests being performed. The medical clinician or technician mayalso forget to correctly document that a fluid sample was obtained orunder what conditions the sample was obtained. Furthermore, theclinician or technician may fail to correctly record which patientprovided a particular fluid sample. These problems may harm the patientor, at minimum, may require that certain fluid sample procedures must berepeated. Therefore, there is a need for a system for fluid delivery toa patient and a system for acquiring a test specimen that assists theclinician or technician in performing and documenting the medicalprocedure. The system should be configured to prevent errors thatcommonly occur during such procedures and should provide visual orauditory alerts when a mistake is made. The system should also beautomatically integrated with existing patient data systems so thatinformation about the type of procedure to perform is easily accessibleto the clinician or technician. Additionally, confirmation that aprocedure was performed and relevant information about the procedure maybe automatically and directly provided to a patient's medical record toensure that patient data is not lost. The systems and methods describedhereinafter are provided to address some or all of these issues.

SUMMARY OF THE INVENTION

The system and method provided herein reduces the risk of medicationinfusion and delivery error and improves clinical workflow foridentifying, confirming, and documenting fluid delivery of medicationand fluids to a patient. These identification, confirmation, anddocumentation activities are accomplished in real-time and at theclinical point of use.

The system is designed to provide such benefits in a hands-free mannerat the clinical point of use. Similarly, a system and method forestablishing a reliable test specimen chain of custody from the point ofcollection through the reporting of results is also provided. The systemallows for an automatic, non-clinically disruptive, hands-free way toestablish specimen identification, collection confirmation, sample andresults tracking, and integration into a patient data system. Finally,the system may further provide enhanced visualization to increasesuccess during an invasive procedure requiring procedural guidance, suchas insertion of a vascular access device. The system and method mayinclude vascular anatomy visualization and mapping, vein and deviceselection assistance, as well as means for vascular access device (orother hypodermic injection device) insertion success and assessment ofan indwelling vascular access device (such as a peripheral IV catheter,blood collection set, peripherally inserted central catheter (PICC),central line, etc.) during use.

In view of these purported benefits, a wearable electronic device forenhancing visualization of an anatomical structure during an invasiveprocedure, such as a vein during a vascular access procedure, isprovided. The wearable electronic device includes: a housing; at leastone imaging sensor enclosed within or associated with the housing; and avisual display integrally formed with or associated with the housing.The device is configured to acquire an image of a vascular access siteof a patient with the imaging sensor, process the image to determine alocation of a preferred vein, and display a virtual vein trace of thelocation to the user via the visual display.

In accordance with an embodiment of the present invention, a wearableelectronic device configured to be worn by a user includes a housing, atleast one imaging sensor associated with the housing, and a visualdisplay integrally formed with or associated with the housing. Thewearable electronic device is configured to acquire an image of aninvasive access site of a patient with the at least one imaging sensor,process the image to determine a location of a desired anatomicalstructure, and display a virtual trace of the anatomical structure tothe user via the visual display.

In certain configurations, the invasive access site is a vascular accesssite, and the desired anatomical structure is a desired vein. Thewearable electronic device may also include a microprocessor formanaging the at least one imaging sensor and visual display, and aprogram for acquiring and processing images from the at least oneimaging sensor.

The wearable electronic device may acquire and process the imagesautomatically, without an input or actuation activity by a user. Thevirtual display may also provide the virtual trace to the user in ahands free manner. In certain configurations, the wearable electronicdevice processes the image to determine the location of the desiredanatomical structure by identifying anatomical markers and determinesthe location of the desired anatomical structure based on a position ofthe anatomical markers. The anatomical markers may be one or more of thefollowing physical locations on the patient's body, including at leastone of the wrist, fingers, thumb, elbow, shoulder, or any combinationthereof. The anatomical markers may also be externally applied markersprovided on the patient's skin or applied to a dressing.

In certain embodiments, the virtual trace is color-coded to signify apreferred catheter gauge for insertion. The wearable electronic devicemay be a head-worn computer, and the visual display may be a projectionprism configured to project a virtual layer to a field of view of theuser. The virtual layer may include the virtual trace and a userinterface. The user interface may include a patient information portion,a schematic drawing showing a position of the invasive access devicerelative to the desired anatomical structure, an invasive access deviceinformation portion, or any combination thereof.

The virtual trace may be positioned in the virtual layer such that theuser sees the virtual trace over the actual invasive access site in thefield of view of the user. The wearable electronic device may alsoinclude a sub-dermal illuminator enclosed within or associated with thehousing. The sub-dermal illuminator may include a radiation beam which,when directed toward the skin. of the patient, increases visibility of asub-dermal structure. The radiation beam may be provided by a lightbulb, light emitting diode, laser diode, laser light tube, or anycombination thereof.

The wearable electronic device may also include a peripheral data entrydevice that allows the user to manually enter data to the wearableelectronic device. The peripheral data entry device may be a motionsensor, gyroscope, pressure sensor, accelerometer, touchpad,touchscreen, or any combination thereof. The wearable electronic devicemay also include a power supply within the housing of the wearableelectronic device.

In certain configurations, the wearable electronic device furtherincludes a data transmission interface for sending data to or receivingdata from an external electronic device. The data transmission interfacemay be configured to send data to and receive data from a patient datasystem. Information received from the patient data system may includeinformation about an invasive procedure to be performed, informationabout an invasive access device required for a particular procedure, orinformation about the patient.

In accordance with another embodiment of the present invention, a systemincludes a wearable electronic device configured to be worn by a user.The wearable electronic device includes a housing and a visual displayintegrally formed with or associated with the housing, and an externalsub-dermal imaging device for providing an image of sub-dermalstructures in close proximity to a vascular access site. The wearableelectronic device is configured to process images obtained by thesub-dermal imaging device to determine a location of a desiredanatomical structure for an invasive access procedure and to display avirtual trace of the location to the user via the visual display.

In certain configurations, the external sub-dermal imaging device isselected from one of the following: an ultrasound monitor, an infraredmonitor, a magnetic resonance imaging monitor, or any combinationthereof. The wearable electronic device may further include one or moreimaging sensors associated with the housing for acquiring an image ofthe invasive access site. The wearable electronic device may beconfigured to process the image of the invasive access site captured bythe one or more imaging sensors to determine positioning of the virtualtrace. The images may be provided by the sub-dermal imaging device anddisplayed to the user via the visual display of the wearable electronicdevice in real time. A sub-dermal image of the invasive access site maybe saved on a data storage medium of the wearable electronic device ortransmitted to an external data storage device via a data transmissioninterface, and the image may be accessible to determine an invasiveaccess site for future invasive access procedures.

In accordance with another embodiment of the present invention, a systemfor vein access confirmation includes a wearable electronic deviceconfigured to be worn by a user. The wearable electronic device includesa housing, one or more imaging sensors associated with the housing, adata reporting accessory for providing data to the user, and at leastone microprocessor for managing and processing images from the one ormore imaging sensors. The system also includes an external sub-dermalimaging device for acquiring images of sub-dermal structures positionedadjacent to a proposed vascular access site. The system also includes avascular access device for insertion into the vein of a patient at thevascular access site. The wearable electronic device may be configuredto process images obtained by the sub-dermal imaging device to determinea preferred vein for insertion of the vascular access device, toestimate a preferred size for an injection portion of the vascularaccess device based on the size of the preferred vein, and to report thepreferred size for the injection portion to the user via the datareporting accessory.

In certain embodiments, the system further includes at least oneidentification tag including or associated with information about thevascular access device, with the at least one identification tag beingattached to or integrally formed with the vascular access device. Theone or more imaging sensors are configured to acquire an image of the atleast one identification tag.

The at least one identification tag may include a two-dimensional barcode, a three-dimensional bar code, a near field communication device,or a label having text readable by an optical character recognitionalgorithm. The wearable electronic device may be configured to identifythe at least one identification tag on the acquired image and to extractinformation from the at least one identification tag including the sizeof the vascular access device. The wearable electronic device may beconfigured to provide an alert to the user when the size of the vascularaccess device is larger or smaller than the size of the preferred vein.Optionally, the wearable electronic device is a head-worn computer, andthe data reporting accessory is a projection prism configured to projecta virtual layer to a field of view of the user.

In accordance with another embodiment of the present invention, a methodfor insertion of a vascular access device to a vein assisted with adevice for enhanced visualization includes the step of capturing animage of a possible vascular access site with a wearable electronicdevice having at least one imaging sensor and a microprocessor forprocessing an image captured by the at least one imaging sensor. Themethod further includes the steps of processing the image to identify apreferred vein location within the vascular access site, and displayinga virtual vein trace at the preferred vein location to a user via avisual display of the wearable electronic device.

In certain configurations, the wearable electronic device is a head-worncomputer, and wherein the visual display is a projection prismconfigured to project a virtual layer, including the virtual vein trace,to a field of view of the user.

These and other features and characteristics of the present invention,as well as the methods of operation and functions of the relatedelements of structures and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and the claims, the singular form of “a”, “an”, and“the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a hands-free system for assuringpatient medication and fluid delivery according to the principles of theinvention.

FIG. 2 is a schematic representation of a field of view display for thesystem of FIG. 1.

FIG. 3A is a schematic representation of a hands-free system forassuring patient medication and fluid delivery having a wearableelectronic device in the form of glasses and a patient identificationdevice, according to the principles of the invention.

FIG. 3B is a schematic representation of a hands-free system forassuring patient medication and fluid delivery having a wearable devicein the form of a wrist-mounted device and a patient identificationdevice, according to the principles of the invention.

FIG. 4 is a schematic representation of a hands-free system for assuringpatient medication and fluid delivery, according to the principles ofthe invention.

FIG. 5 is a schematic representation of a hands-free system forestablishing identification of a test specimen and for sample tracking,according to the principles of the invention.

FIG. 6 is a schematic representation of a field of view display for thesystem of FIG. 5.

FIG. 7 is a schematic representation of a system for enhancedvisualization during insertion of an invasive device, according to theprinciples of the invention.

FIG. 8 is a schematic representation of a system for enhancedvisualization during insertion of the invasive device, according to theprinciples of the invention.

FIG. 9 is a schematic representation of a field of view for the systemof FIG. 8.

FIG. 10 is a schematic representation of a field of view for the systemof FIG. 9.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention. However, it is to be understood that the inventionmay assume various alternative variations and step sequences, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices and processes illustrated in the attacheddrawings, and described in the following specification, are simplyexemplary embodiments of the invention. Hence, specific dimensions andother physical characteristics related to the embodiments disclosedherein are not to be considered as limiting. For the purpose offacilitating understanding of the invention, the accompanying drawingsand description illustrate preferred embodiments thereof, from which theinvention, various embodiments of its structures, construction andmethod of operation, and many advantages may be understood andappreciated.

The present invention is directed to systems and methods for hands-freeidentification, confirmation, and documentation of various medicalprocedures at the clinical point of use, including invasive proceduresrequiring procedural guidance. Example procedures include, but are notlimited to, medication and fluid delivery, specimen or samplecollection, and/or vascular access procedures. The system improves onexisting patient data systems by collecting and recording data withoutrequiring affirmative acts by a user or operator, referred tohereinafter as a medical technician. More specifically, the systemsallow a user or operator, referred to hereinafter as a medicaltechnician, to perform necessary identification, conformation, anddocumentation activities without being required to manually recordinformation or manipulate data input devices, such as scanners, cameras,keyboards, or touchscreens, as is required by presently existing patientdata systems. The system improves clinical workflow and data inputintegrity by reducing the possibility of technician error. Additionally,the system reduces the risk of infection for patients and medicaltechnicians. Specifically, since the medical technician is not requiredto touch or operate a data input device, the risk that the input devicewould become contaminated is reduced.

The system may be integrated with existing equipment, includingdisposable medical devices already being used, as well as existingpatient databases and patient monitoring software. Thus, the system doesnot require additional equipment or capital infrastructure improvementson the part of the medical facility. Similarly, the system can be easilyintegrated with procedures and practices of a specific medical facility.

With reference to FIG. 1, a system 10 a for hands-free assurance andverification of fluid delivery to a patient at the clinical point of useis illustrated. The system 10 a effectively obtains data about the fluiddelivery to be performed from an external source, such as a patient datasystem, documents that the fluid procedure is performed, and sendsconfirmation of the procedure to an external source. The system 10 a isprovided for the purpose of reducing the risk of medication error at thepoint of administration by providing real-time patient information,alerts, medication identification, and dose confirmation in a hands-freemanner.

The system 10 a includes a wearable electronic device. In a preferredand non-limiting embodiment, the wearable electronic device is awearable computer with an augmented reality display, referred tohereinafter as a “wearable electronic device 18”. An exemplary wearableelectronic device 18 may be a head-worn device, such as glassesincorporating Google Glass technology, created by Google Corp., ofMountain View, Calif. While the Google Glass technology is not presentlycommercially available, it is believed that once Google Glass or asimilar product becomes commercially available, it could be easilyimplemented into the invented system by one having ordinary skill in theart. Alternatively, the wearable electronic device 18 may be a head-wornface-shield also incorporating Google Glass technology. In a furtherembodiment, the wearable electronic device 18 may be a wrist-mounteddevice also incorporating Google Glass technology. The wearableelectronic device may also have other shapes and configurations, basedon the particular fluid delivery procedure being performed. For example,the wearable electronic device may be a button or pin attached to themedical technician's clothing, a watch worn about the wrist, necklace,pendant, or any other sort of unobtrusive and easily carried item.

The wearable electronic device 18 may include a hat, helmet, faceshield, wristband, or frame 20 (e.g., a frame for a pair of glasses)having a display portion 16, such as a projection prism, face shield, orwrist worn display that extends into the field of view of the medicaltechnician. The display portion 16 may be placed in close proximity to awearer's eye, such as in the case of a projection prism. The displayportion 16 is configured to present a virtual layer, such as theprojected layer of FIG. 2, within the wearer's field of view that isequivalent to a larger screen viewed from a farther distance away. Forexample, in the instance of the display portion 16 being a projectionprism, the projection prism may be positioned less than an inch from thewearer's eye, but presents a viewable screen that appears as a 25 inchscreen viewed from 8 feet away. The augmented reality display projects avirtual projection or layer 22 that covers a portion of the wearer'sfield of view. The medical technician's entire field of view is notobscured by the virtual layer 22. The medical technician can still “see”a reality layer 24 beyond or adjacent to the virtual layer 22.

In other embodiments, the data display portion 16 of the wearableelectronic device 18 may be a visual display, such as a standard monitorfor a computer or smart phone. Standard monitors include liquid crystaldisplays (LCD) and light emitting diode (LED) displays. The monitor maybe integrally formed with the wearable electronic device or may be anexternal screen or device viewable by the technician. The wearableelectronic device 18 may also communicate treatment and patientinformation to the technician through other communication meansincluding, but not limited to, audio alerts or tactile confirmation. Forexample, the wearable electronic device 18 may beep or vibrate to signalto the technician that a problem was identified.

The wearable electronic device 18 further includes a computer housing 26or enclosure attached to the frame 20. The housing 26 may be any sizenecessary to hold the required associated electronics. The associatedelectronics within the computer housing 26 may include data collectiondevices and sensors, data transmission and communication circuitry, dataprocessing circuitry, and data display and alert devices and circuitry.Desirably, the computer housing 26 is small and lightweight enough thatit does not pose a substantial hindrance to a wearer or operator as theoperator performs normal functions and activity.

The data collection devices may include a variety of sensors andrecorders for obtaining information about the medical procedure beingperformed. For example, the data collection function may include one ormore image capture devices 12, such as digital cameras, for image orvideo capture. In certain embodiments, the image capture device 12 maybe adapted to provide a still or running two-dimensional image orimages, or a three-dimensional anatomical scan geometry. An image orvideo camera usually consists of a charge-coupled device (CCD) orcomplementary metal-oxide-semiconductor (CMOS) imaging sensor, a lens, amultifunctional video control/digital signal processing (DSP) chip, anda set of discrete components (e.g., capacitor, resistors, andconnectors). The video control/DSP chip may be integrally formed withthe camera 12. Alternatively, image processing may be performedelsewhere on the wearable electronic device, or even at an externalcontroller or computer. The lens may include a focus range useful forimaging as described herein or the video cameras may include anauto-focus feature. Likewise, the lens may be equipped with a zoomfunctionality. While the video control component on the chip performs anumber of image acquisition tasks, the DSP component on the same chipimplements data processing algorithms, such as noise reduction andsimple forms of data compression and encryption. The digital output fromthe video control/DSP chip may be in either a parallel or a serial form,depending on the particular chip design and the input configuration inthe next data processing or interface stage. The system may also includemicrophones for auditory (e.g., voice command) input, touch mechanismsor track pads for tactile input, accelerometers, gyroscopes, and thelike.

The electronic communication and data transmission devices andelectronic circuitry may include a data transmission interface 14 forsending and receiving data to and from external sources, such as anexternal electronic device. The external device may be a data storagedevice, external computer, a local computer network consisting of anumber of computing devices, or the Internet. For convenience, theseexternal electronic devices will be collectively referred to as thecloud 15. The data transmission interface, in effect, creates a personalarea network (PAN) including the wearable electronic device 18, a datatransmitter and an external receiver attached to an external source. APAN is a computer network used for communication (e.g., datatransmission) among computer devices including telephones and personaldigital assistants (PDAs) in close proximity to the technician's body.PANs can be used for communication among the personal devices themselves(intrapersonal communication), or for connecting to a higher levelnetwork and the Internet (an uplink). Networks may be wired using, e.g.,USB, ethernet, and FireWire protocols. A wireless personal area network(WPAN) is made possible with wireless network technologies such asBluetooth®, WiFi, Z-Wave, and ZigBee. WiFi (e.g., IEEE 802.11a, b, g, n)networking protocols may be used, which advantageously have a greatertransmission range than Bluetooth®, but consequently also have greaterpower consumption. Suitable external sources for receiving datatransmitted from the device and optionally processing the data include acomputer, tablet PC, or smart phone and/or an external hard drive orother device for backing up stored data.

In certain embodiments, the data transmission interface 14 is integratedwith an existing patient data system or database. Mobile patient dataacquisition and recording systems integrated for use with handheldelectronic devices, such as smart phones, may also be integrated withthe data transmission interface 14. These systems may allow users toremotely update patient data using the handheld electronic device. Theupdated information is transferred to a data storage location, where itcan be accessed for future use. Commercially available softwareplatforms may be used to coordinate recording patient data, and mayinclude features for making such data easily accessible at the point ofcare. As a result of integration with such existing database softwareplatforms, the presently invented system 10 a is capable ofautomatically updating patient data stored on a patient data system ordatabase as a procedure is being performed. However, unlike existingsystems, the present system 10 a updates patient data automatically,without direct input from the medical technician. Thus, the system 10 ais fully and automatically integrated to the patient data system. Incontrast, previously, data was manually entered by the medicaltechnician after a procedure was performed.

In certain embodiments, the wearable electronic device 18 may alsoinclude a data storage device 21 integrally formed with the computerhousing 26. In one non-limiting embodiment, the storage device 21 is adigital data recorder, such as a disk drive, which records data onto astorage medium. In another embodiment, the storage medium is flashmemory. The storage medium is any type of non-volatile memory, forexample, magnetic data storage media such as a hard disk drive ormagnetic tape, or flash-based memory. Flash memory is a non-volatilecomputer storage chip using NAND or NOR type memory as found in Micro SDcards, USB flash drives, or solid-state drives. File systems optimizedfor flash memory (solid state media) include Embedded Transactional FileSystem (ETFS), exFat, and FFS2 systems. The storage medium can be randomaccess memory (RAM) or read only memory (ROM). The memory may beremovable from the device or permanently installed within the housingand transferable to an external device through the data transmissioninterface 14.

In one embodiment, the wearable electronic device 18 further includesone or more power supplies, such as a battery 23 included in thecomputer housing 26. A battery 23 comprises one or more electrochemicalcells that convert stored chemical energy into electrical energy. Onenon-limiting example of a useful battery is a lithium-ion battery. Alithium-ion battery is a rechargeable battery often used in electronicdevices. It is preferable that the capacity of the lithium-ion batteryis sufficient to power the wearable electronic device for an entire day,or longer. In some cases where the device is not operated continuously,however, a battery of smaller capacity is more appropriate for reduceddevice size and weight. Other types of batteries adaptable for use inthe device include nickel cadmium (NiCd) and nickel metal hydride (NiMH)batteries. Preferably the battery 23 is rechargeable and, in that case,the device further includes a battery recharge port.

The electronic devices and electronic circuitry included in the housing26 of the wearable electronic device 18 are controlled by one or morecontrollers, such as microprocessors. A microprocessor is a chipcontaining one or more integrated circuits which receives data andprocesses the data according to instructions stored in the chip'smemory. A microprocessor typically, along with other functions, managesthe collection of data from the various sensors and the digital cameras12, directs the storing of data by the data storage system, andallocates system resources between the electronic components to reducepower consumption and decrease the need for duplicative electronicsystems. The microprocessor may include software for controlling variousdata collection and software for processing collected data. Similarly,the microprocessor may include software for displaying collected data,as well as for interacting with the technician. Alternatively, thecontroller may facilitate transfer of data and instructions between thewearable electronic device and an external processing device, such as anexternal computer or workstation.

With continued reference to FIG. 1, the system 10 a includes a fluiddelivery apparatus 28, such as a pre-filled syringe, pen injector,auto-injector, infusion set, catheter, or any combination thereof. Thewearable electronic device 18 is configured to identify and recognizethe fluid delivery apparatus 28. To facilitate identification andrecognition, the fluid delivery apparatus 28 may include anidentification tag 30 integrally formed with or affixed thereto. Theidentification tag 30 may be a standard two-dimensional bar code,three-dimensional bar code (e.g., a quick read (QR) code), as well asvarious proprietary encoded computer-readable tags and labels, as areknown in the art. The identification tag 30 may be integrally formed onor within the fluid delivery apparatus 28. Alternatively, theidentification tag 30 may be printed on the fluid delivery apparatus 28or printed on a label that is adhered to the fluid delivery apparatus28. In either case, the wearable electronic device 18 is configured toidentify the identification tag 30 and to extract information therefrom.The identification tag 30 may provide information about the fluiddelivery apparatus 28 and fluid contained therein, including medicationtype, total fluid volume, manufacturer, needle dimensions, fluidexpiration date, and the like.

In certain embodiments, the wearable electronic device 18 may includeimage processing functions for identifying and extracting data from animage of the identification tag 30 captured by the digital camera 12.The image processing function may be configured to identify variouspositional markers on the fluid delivery apparatus 28. The positionalmarker may point to the identification tag 30 and may trigger thewearable electronic device 18 to begin capturing images of theidentification tag 30. Once a suitable image is captured, the imageprocessing function evaluates the image and extracts information fromthe identification tag 30. The image processing function may alsoinclude a time delay of, for example, three (3) seconds, meaning thatthe wearable electronic device 18 does not begin attempting to processor read the image of the identification tag 30 until the positionalmarker has been in the field of view for at least three seconds. Thetime delay function preserves computing capacity by restricting whenimage processing occurs. Particularly, only identification tags 30 thatare interesting enough for the technician to view for several secondsare scanned to extract information therefrom. In certain embodiments,identification tags 30 that are not within the technician's field ofview for at least three seconds are assumed to be unimportant and, assuch, are not read.

Alternatively, the identification tag 30 may be a standard medical labelincluding the name of the medication or therapeutic agent and volume instandard printed characters. The wearable electronic device 18 may beconfigured to capture an image of the label and to read the informationcontained thereon. For example, the system 10 a may include an opticalcharacter recognition algorithm configured to extract data from printedtext, such as a printed medical label. Thus, the system may be used withexisting fluid delivery apparatuses 28 and syringes and may not requirethat additional tags or electronic locator devices be added.

In another alternative embodiment, the identification tag 30 may be anear field communication (NFC) device, such as a radio frequencyidentification (RFID) tag or electronic device capable of projecting areadable signal that could be identified and read by a scanner,transmitter, or antenna associated with the wearable electronic device18. Inclusion of an NFC device, or RFID tag, simplifies the dataextraction process. Particularly, no image processing is required toextract information from the NFC device or RFID tag.

In certain embodiments, the identification tag 30 may be printed orattached to the fluid delivery apparatus 28 using a selectively visibletype of ink that is only readable at particular times, such as justbefore fluid delivery occurs. After fluid delivery is complete, adifferent or modified identification tag 30 may become visible tosignify end of use or that an injection is completed.

The system 10 a may also include means for identifying when fluiddelivery has occurred and, optionally, for estimating the fluid deliveryvolume. The system 10 a may monitor fluid delivery by tracking movementof an actuation mechanism or fluid expulsion mechanism, such as aplunger 32 or piston rod 34, during the fluid delivery procedure. Incertain further embodiments, the identification tag 30 may be used toestimate the position of the plunger 32 or piston rod 34. For example,image processing software could record the initial position of a plunger32 or piston rod 34 relative to the position of the identification tag30. When the plunger 32 or piston rod 34 moves relative to the positionof the identification tag 30, the image processing software determinesthat an injection has begun. When the plunger 32 or piston rod 34advances a predetermined distance from the identification tag 30, it maybe assumed that the injection is complete.

The system 10 a may also be configured to automatically identify theposition of the plunger 32 or piston rod 34 relative to other markers onthe fluid delivery apparatus 28. In certain embodiments, the markingscould be graduated lines or indicia on a syringe barrel. In that case,the movement of the plunger 32 or piston rod 34 relative to the markingscould determine not only initiation and dose, but also fluid volumedelivered. In further embodiments, the plunger 32 may include a coatingor indicator that is easily identifiable on an image captured by thedigital camera 12. Alternatively, the coating could be easily detectablefrom another scanning element, such as an ultraviolet light or infrareddetector. Such a device or scanner could be associated with the wearableelectronic device 18. Enhancing the visibility of the plunger 32improves recognition by the image processing functionality and mayimprove volume estimation by allowing for more exact determination ofplunger 32 location.

In certain embodiments, additional electronic or mechanical sensorscould be associated with the fluid delivery apparatus 28 to providefurther evidence or confirmation of fluid delivery. For example, sensorscould be placed near an injection needle 36 of the fluid deliveryapparatus 28. The sensors may record when the needle 36 is correctlyinserted in a patient and ensure that fluid passes through the needle 36and is expelled to the patient. Data collected by the sensors could betransmitted to the wearable electronic device 18 by a wirelesstransmitter, desirably a wireless transmitter, such as Bluetooth®,adapted for short range communication. Including a sensor directly onthe fluid delivery apparatus 28 increases the complexity of the fluiddelivery apparatus 28 and associated electronics, but, advantageously,provides additional assurance that fluid delivery to a patient actuallyoccurs.

In addition to being used to locate and read the identification tag 30and to provide end of dose confirmation, the image capture functionalityof the wearable electronic device 18 may also be relied upon to archiveand document the fluid delivery procedure. For example, images of theinjection process (e.g., the insertion of the needle into the patient'svein), an image of an empty syringe, and an image of a discarded syringecould be obtained and included in the patient's electronic record. Eachof these images may be embedded with a time stamp. The time stamp couldbe used to update the patient's medical record with the exact time whena procedure was performed.

The wearable electronic device 18 is configured to present datacollected by the image capture and other functions of the system to thetechnician in an easy to use and easily accessible manner. Desirably,data is presented to the technician in a clear and concise mannerdirectly within the technician's field of view via the display portion16 of the wearable electronic device 18.

An exemplary field of view 100, as seen by a technician wearing awearable electronic device 18 and including both the virtual layer 22and reality layer 24, is depicted in FIG. 2. As shown in FIG. 2, thevirtual layer 22 includes a user interface 110. The user interface 110may include a heading bar 112 or title with information about thepatient, such as the patient's name and patient identification number.The heading bar 112 or title may also include a description of themedical procedure to be performed or information about the type ofinjection or fluid delivery device required. The user interface 110 mayalso include a syringe volume indicator icon 114 showing estimated fluidremaining in the syringe. The icon 114 allows the operator to easilydetermine when all fluid is injected to the patient and, thus, acts asan end of dose indicator. Finally, the user interface 110 may alsodisplay an identification tag confirmation icon 116. The icon 116 couldshow when an identification tag 30 has been identified on an imageobtained by the image capture functionality. Furthermore, theidentification tag confirmation icon 116 could show confirmation thatthe identification tag 30 is correct, such as when the fluid deliveryapparatus 28 needed for the particular procedure being performed isrecognized. If the identification tag 30 cannot be located or if anincorrect identification tag 30 is found, the icon 116 may display analert, signifying to the technician that the injection should not beperformed.

As described above, the virtual layer 22 does not block the operator'sentire field of view 100. Thus, the operator still sees the realitylayer 24 even when the user interface 110 is in view. Accordingly, thetechnician can see any alerts while preparing to perform the procedure.As a result, the possibility that the technician would miss an alertbecause he or she is busy preparing for the fluid injection iseffectively reduced.

With reference to FIG. 3A, a system 10 b for assuring patient medicationor fluid delivery, according to a further embodiment, is illustrated.The system 10 b includes a wearable electronic device 18 having a frame20 in the form of head-worn glasses. In the system 10 b of FIG. 3A, thewearable electronic device 18 may be used to visualize the fluiddelivery apparatus in step (a), as described elsewhere herein, and tovisualize a patient ID 38 in the form of a wristband 40 worn about thepatient's wrist, in step (b). It is noted herein that steps (a) and (b)may be accomplished in any order. The wristband 40 includes anidentification tag 42 with a QR code. The patient ID 38 may also includea unique visual marker or indicia near the identification tag 42 or QRcode to trigger the image capture functionality of the wearableelectronic device 18. When the unique marker is identified, the wearableelectronic device 18 having a frame 20 in the form of head-worn glassesbegins processing the captured image to find and read the QR code. Thepatient ID 38 may also include additional encoding or identificationtechnologies, such as an NFC tag (e.g., RFID), visual coding, such astext, that can be identified and read by image processing functionality,Bluetooth® or similar short range data transmission antenna, and otherproximity sensing technologies. The patient ID 38 includes informationabout the patient and may, optionally, be linked directly to anelectronic patient record on a patient data system. The patient ID 38may further include location-providing technology, such as GPS, fordetermining the location of the patient. The technician can scan thepatient ID 38 to obtain information about the patient, such as theprocedure to be performed, or a schedule for when future fluiddeliveries should be performed, as well as any known medical conditionsof the patient. Since the patient ID 38 links the wearable electronicdevice 18 to the patient's electronic record, any information ordocumentation taken during the procedure, such as time of the injection,duration of injection, or amount of fluid injected, can be transmittedto and stored with the patient's electronic record. As discussed herein,the display of information is provided to the wearer of the wearableelectronic device 18 in the glasses-mounted display 16, as describedwith reference to FIG. 1.

With reference to FIG. 3B, a system 10 b for assuring patient medicationor fluid delivery as described above with reference to FIG. 3A is shownin which the wearable electronic device 18 is provided in the form of awrist-mounted display 19, such as a SmartWatch. The system of FIG. 3Bfunctions similarly to the system of FIG. 3A, with the exception thatthe display 16 is coordinated through the wrist-mounted display 19,which provides similar functionality to the display 16, as describedherein but with a physical positioning on the wrist of the user. In thesystem 10 b of FIG. 3, the wearable electronic device 18 may be used tovisualize the fluid delivery apparatus in step (a), as describedelsewhere herein, and to visualize the patient ID 38 in the form of awristband 40 worn about the patient's wrist, in step (b). It is notedherein that steps (a) and (b) may be accomplished in any order.

With reference to FIG. 4, a further embodiment of a system 10 c forassuring fluid delivery to a patient is depicted. The system 10 c isused for administering fluid to a patient through a fluid deliveryapparatus 28, such as an infusion set 44, including various fluidcontainers 46, namely intravenous therapy (IV) bags, associated tubing48, and a catheter 50 extending into the vein of a patient. The tubing48 may further include one or more access ports 52. Syringes 54 can beconnected to the access ports 52 for providing additional or differenttypes of medical fluid to a patient. As in previously describedembodiments, the system 10 c includes a wearable electronic device 18,the fluid delivery apparatus 28, and identification tags 30 readable bythe wearable electronic device 18. The identification tags 30 include orare associated with identifying information about the fluid deliveryapparatuses 28. The system 10 c confirms the procedure to be performedand fluid to be injected, identifies the devices and apparatus needed,confirms that fluid is being administered to the patient, and documentsthe procedure.

In certain embodiments, the system 10 c may be configured to confirmthat the infusion set 44 is correctly installed and connected. Forexample, the image processing functionality may identify variousconnection points of the infusion set 44, fluid containers 46, andcatheter 50. The system 10 c would then confirm that the elements areconnected correctly. If a suitable connection is not recognized, thesystem 10 c may alert the technician to check the connection beforebeginning the fluid delivery. The system 10 c may also provide variousother device maintenance alerts. For example, the system 10 c may alertthe technician when a predetermined indwell time limit is reached.Similarly, the system 10 c may alert the technician at various intervalswhen system maintenance should be performed.

In certain further embodiments, the system 10 c is configured tovisually monitor drip count of the infusion set 44 to establish andconfirm fluid delivery rates. For example, the image capturefunctionality of the wearable electronic device 18 may document the timeof insertion of the catheter 50. The image capture functionality willthen record the outflow port of the fluid container 46 for apredetermined period of time to record drops of fluid flowing from thecontainer 46 into the infusion set 44. The image processingfunctionality of the wearable electronic device 18 identifies individualfluid drops to estimate fluid delivered to the patient over a period oftime. The system 10 c may be configured to provide an alert when asufficient period of time has passed for delivery of a predeterminedfluid volume.

With reference to FIGS. 1-4, when using the system 10 a, 10 b, 10 c thetechnician puts on the wearable electronic device 18. For example, thetechnician may put on the wearable electronic device 18 at the beginningof a shift, or before starting to perform a particular injection orfluid delivery procedure. When the wearable electronic device 18 is inplace and turned on, the wearable electronic device 18 may display astart screen providing the technician with initial instructions, such asa task list with patients to visit and procedures to perform. Thewearable electronic device 18 may also ask the technician to confirm hisor her identity to ensure that the correct individual is given thecorrect instructions. When first coming into contact with a patient, thetechnician uses the wearable electronic device 18 to capture an image ofthe patient ID 38. Based on information on or associated with thepatient ID 38, medical information about the patient, including theinjection to be performed, is obtained. The obtained information isdisplayed on the user interface 110, along with instructions forperforming the procedure. Based on the displayed instructions, thetechnician may obtain items needed for the injection, including anappropriate fluid delivery apparatus 28 and, if necessary, a medicalfluid vial or cartridges to load into the fluid delivery apparatus 28.When the operator “sees” the injection apparatus and other items in hisor her field of view 100, the wearable electronic device 18 identifiesand reads identification tags 30 attached to the items. The system 10 a,10 b, 10 c may check the obtained medical items to ensure that onlyitems necessary for the procedure are obtained and to ensure that noadditional items are needed. As items are obtained and identified by thesystem, the instructions on the user interface 110 are updated. Forexample, if a correct item is obtained, a confirmation message may bedisplayed to the user interface 110. If an incorrect item is obtained,an alert may be presented to the technician. The alert may be visual,such as an icon displayed in the user interface 110, as well as tactile,auditory, or any combination thereof.

Once the items are obtained, the technician performs the medicalprocedure. As the technician performs the procedure, the injectionactivities are monitored to verify the injection. For example, thewearable electronic device 18 may ensure that the needle 36 is insertedinto the skin of the patient and may ensure that fluid is expelled fromthe fluid delivery apparatus 28. Information, including the time anddate of the injection and name of the technician, may be recorded andtransmitted to an external system, such as a patient data system. Thus,the collected information may be automatically included in the patient'sdigital record. The information may also be transmitted for billingpurposes or, if necessary, to third party insurers.

In certain further embodiments, the time and date information can beused for establishing a baseline for future medical procedures. Thebaseline may be used to determine for how long an infusion should beperformed, or to set times for checking the infusion set 44. Similarly,in the case of injections from syringes or injectors, the baseline timedata can be used to schedule subsequent treatments. Based on thisinformation, the system 10 a, 10 b, 10 c may be configured to showwarnings or alerts in the user interface 110 when the subsequenttreatment should be provided.

According to another aspect of the invention and with reference to FIGS.5 and 6, a system 10 d and method for obtaining a test specimen formedical testing and diagnosis is illustrated. Advantageously, the system10 d provides for an automatic, non-clinically disruptive, hands-freeway to establish specimen identification, collection confirmation,sample and results tracking, and integration into the patient datainformation system. The system 10 d is configured to track the chain ofcustody of a fluid sample starting at the time the sample is obtainedand may continue through sample testing or reporting results.Furthermore, the system 10 d may be automatically integrated withexisting patient data systems, so that information about the type ofsample to be collected and tests being performed can be displayed to thetechnician.

As in previously described embodiments, the system 10 d includes awearable electronic device 18. The system 10 d also includes a bloodsampling device 56, which may be part of a larger extravascular fluidcollection system. The blood sampling device 56 provides a fluidconnection between the larger extravascular fluid collection system andthe interior of a specimen collection container 55. The blood samplingdevice 56 generally includes a spike or port at a distal end thereof.The specimen collection container 55 can be inserted onto the spike orport for collection of a fluid sample through the blood sampling device.The blood sampling device 56 may also be configured to release a smallamount of fluid sample, such as a discrete number of fluid drops,through a proximal opening of the blood sampling device 56. Theextravascular system includes the blood sampling device 56, the specimencollection container 55, extension tubing 57, and an invasive accessdevice, such as a vascular access device (shown in FIG. 10).Alternatively, the sampling device 56 may be directly connected to anintravenous catheter hub without additional components such as theextension tubing 57, to reduce the number of components and simplify thecollection and sampling process.

The system 10 d may further include a point-of-care testing device 58.Test strips, glass slides, and diagnostic cartridges are point-of-caretesting devices 58 that receive a blood sample and test the blood forone or more physiological and biochemical states. Examples of testingcartridges include the i-STAT® testing cartridge from the Abbot group ofcompanies. Testing cartridges such as the i-STAT® cartridges may be usedto test for a variety of conditions including the presence of chemicalsand electrolytes, hematology, blood gas concentrations, coagulation, orcardiac markers.

As is known in the art, the blood sampling device 56 may be disconnectedfrom the extravascular fluid collection system as shown by arrow 210.The disconnected blood sampling device 56 is used to introduce a portionof the fluid sample to the point-of-care testing device 58, as shown byarrow 212. The fluid sample causes the point of care testing device 58to change color or to undergo some other identifiable transformation toidentify the presence or absence of certain analytes in the fluidsample, when-read by and used with a testing instrument. In certainembodiments of the system 10 d, the wearable electronic device 18 may beconfigured to capture an image of the used point-of-care testing device58. The image processing functionality may be configured to read thepoint-of-care testing device 58 and determine test results.Alternatively, the image may be transmitted to a remote location, whereit can be read or interpreted by an appropriate medical professional.

As in previous embodiments of the system 10 d, the system 10 d includesidentification tags 30 attached to the various containers or bloodsampling devices 56, invasive access devices, such as vascular accessdevices, and point-of-care testing devices 58. The identification tags30 include or are associated with identifying information about thecontainer or device. The identifying information may include the type ofblood sampling device 56 or container, procedure the container or deviceis used for, or fluid volume of the sample obtained. The identifyinginformation may also include a unique designation for each container,allowing the system 10 d to track the container once a fluid sample isdeposited therein. As in previously described aspects of the invention,the identification tags 30 can be any type of indicia, such as a barcodeor QR code, that can be read by the image capture capabilities of thewearable electronic device 18. The identification tag 30 may also be anNFC tag, such as an RFID tag, that can be read by an antenna ortransmitter associated with the wearable electronic device 18.

The system 10 d may also include a patient ID 38, such as a wrist band40 worn by the patient. The patient ID 38 includes an identification tag30, such as a QR code, including or associated with patient information.The patient ID 38 allows the wearable electronic device 18 to access thepatient's electronic information, such as patient information stored onan external patient database system. The wearable electronic device 18is configured to receive the patient data and to display relevantinformation to the technician.

With reference to FIG. 6, the wearable electronic device 18 allows thetechnician to see a virtual layer 22 including a user interface 110. Theuser interface 110 is designed to provide relevant and importantinformation to the technician in a manner which is easy to understand.An exemplary user interface 110 is illustrated in FIG. 6. It isunderstood, however, that the information, content, and design of theuser interface 110 may be adapted for a particular type of medicalfacility or medical procedure. The appearance of the interface 110 mayeven be adapted based on the preferences of a particular technician.

The user interface 110 includes one or more information portions thatdisplay information about the patient, test being performed, containersbeing used, and other relevant data. For example, the user interface 110may include a portion 118 with patient identifying information, such asa patient ID number. The patient information portion 118 may alsoinclude information about the type of sample ordered and a visualconfirmation when the ordered sample is obtained. The user interface 110may also include an identification tag portion, such as anidentification tag confirmation icon 116. The identification tagconfirmation icon 116 may include a visual indication when anidentification tag 30 has been recognized and read correctly. The userinterface 110 may also include a sample collection portion 120, showingan icon 122 of the sample collection container, such as a test tube. Theicon 122 may change appearance when the sample is safely sealed in thecontainer. In certain embodiments, the icon 122 may visually illustratethat the container is being filled with the fluid sample and may displaya visual alert when a sufficient fluid volume has been obtained.

In use, the technician may begin by scanning the patient ID 38 byplacing the patient ID 38 within the field of view 100 of the wearableelectronic device 18, so that the patient information can be read by thewearable electronic device 18. Based on the patient information, detailsabout the patient and test to be performed are displayed to thetechnician on the user interface 110. The technician may then collectthe blood sampling device 56 and other items needed for the particularprocedure to be performed. In certain embodiments, the wearableelectronic device 18 may recognize each item as it is obtained by thetechnician by, for example, recognizing and reading an identificationtag 30 affixed to the item. The user interface 110 may inform thetechnician after each required item is acquired. The user interface 110may also display an alert if a required item has not yet been acquiredor recognized.

The user interface 110 may then display instructions for obtaining thefluid sample. These instructions may include the fluid volume required,suggested vascular access sites, or any other relevant information. Thetechnician then collects the sample into the blood sampling device 56 oranother suitable container. The image capture feature of the wearableelectronic device 18 may capture images of the sampling device 56 orcontainer being filled by the sample and may alert the technician when asufficient fluid volume is obtained. Once the sample is obtained, thetechnician may seal the sampling device 56 or container. The imagecapture functionality of the wearable electronic device 18 may documentthat the sample has been obtained and record the time and a uniqueidentification number for the sampling device 56 or container. In thisway, the container is electronically tied to the particular patient andthe possibility that a sample will be lost or identified with the wrongpatient is reduced.

If point-of-care testing is to be performed, details about performingthe test may be presented to the technician. The technician prepares thetesting device 58 by, for example, placing it on a table or othersuitable surface. Preferably, the surface is white or a similarhigh-contrast color to improve the quality of an image of the testingdevice 58 taken by the wearable electronic device 18. The identificationtag 30 of the testing device 58 is identified and recorded by the imagecapture functionality. The technician may then perform the test by, forexample, placing a drop of the fluid sample on the testing device 58.The system 10 d may wait a predetermined period of time for the test tobe performed and then obtain an image of the used testing device 58. Thecaptured image may be processed to determine test results.Alternatively, the technician may visually determine test results andrecord the information using data input functionality of the wearableelectronic device 18. If the testing device 58 must be preserved andsent to a laboratory or other facility, then the image capturefunctionality may record the identification tag 30 and identificationinformation about the specific testing device 58 used to ensure correctchain of custody. As in previous embodiments of the system 10, thewearable electronic device 18 monitors each step of the sampleacquisition and testing process. If the technician misses a step, theuser interface 110 would alert the technician and provide instructionsfor correcting any mistakes.

According to another aspect of the invention and with reference to FIGS.7-10, a system 10 e for enhanced visualization during insertion of aninvasive access device, such as vascular access device 60, andassessment of an indwelling vascular access device 60 is illustrated.The vascular access device 60 may be any suitable device for injectingor acquiring a fluid sample from a vein, including, but not limited to,a syringe, hypodermic needle, peripheral intravenous catheter, bloodcollection set, central line, or any combinations of these elements.Exemplary vascular access devices 60 include straight and portedintravenous catheters such as the AUTOGUARD™ shielded catheter byBecton, Dickinson and Company, integrated peripheral intravenouscatheters, winged needle sets, and blood collection sets. An exemplarycatheter for use with the system is depicted in FIG. 10. As inpreviously described embodiments, the system 10 e may be integrated witha patient data system for identifying a medical procedure to beperformed and for treatment confirmation.

The system 10 e includes a wearable electronic device 18 described indetail above. The system 10 e further includes the vascular accessdevice 60. The vascular access device 60 may include one or moreidentification tags 30 including or associated with information aboutthe vascular access device 60. The information may include the needlegauge and length, as well as other relevant information required for aparticular procedure. The system 10 e may further include a patient ID38 (shown on FIG. 3) worn by the patient. The patient ID 38 allows thesystem 10 e to automatically identify the patient and may be linked tothe patient's electronic record.

In certain embodiments, the wearable electronic device 18 also includesor is associated with additional systems, such as ultrasonic or otherscanning devices which externally or internally enhance anatomicalstructures. This enhanced anatomical structures may assist thetechnician in positioning the vascular access device 60 by providing avisual indication (e.g., a virtual trace 62) of the location of a veinsuitable for needle insertion. The technician can orient the needle ofthe vascular access device 60 based on the position of the virtual trace62.

In certain embodiments, the virtual trace 62 is projected to the fieldof view 100 of the technician using the display functionality of thewearable electronic device 18. The virtual trace 62 may be acomputer-generated image or icon indicating where a vein is present. Theposition of the vein may be determined by a number of different imageprocessing techniques. In one embodiment of the system 10 e, an image ofthe injection site is captured by the image capture functionality of thewearable electronic device 18. Image processing performed on thecaptured image identifies various anatomical markers on the image. Forexample, the anatomic position of portions of the arm (e.g., wrist,elbow, fingers, etc.) may be identified. In an alternative embodiment,anatomical markers may be placed directly on the exterior of thepatient's skin or applied to a dressing. Based on the location of theseanatomical markers, distance between the markers, and orientation of thearm relative to the image capture functionality, the size and shape ofthe arm can be calculated. Once the position and size of the arm isidentified, approximate vein position can be estimated. The virtualtrace 62, based on these estimates, is projected to the field of view100 of the technician in the approximated position. The virtual trace 62is viewable over the reality layer 24 of the field of view 100,including the patient's arm.

With reference to FIG. 8, in certain embodiments, the visualizationbased on anatomical positioning is enhanced based on readings obtainedusing various external imaging devices, such as ultrasound, infraredimaging, magnetic resonance imaging (MRI), or combinations thereof. Asshown in FIG. 8, the system 10 e is provided with an external ultrasoundmonitor 64 comprising a control module 66 and attached to a wand 68 orscanner. The control module 66 may include an integrated display. Theultrasound monitor 64 may be used to obtain an initial image of thepatient's vascular anatomy prior to performing the invasive procedure.The ultrasound image obtained may be helpful for automaticallydifferentiating between arteries and veins, may help to determine whichvein is most suitable for a particular vascular access, and may assistin selecting a correct catheter size and length for a particular vein.The image of the injection site captured by the digital camera 12 may becaptured simultaneously with obtaining an ultrasound scan to facilitatelining up the two images.

Once the images are obtained and a desirable invasive access site andvein is determined, this location information is transmitted to thewearable electronic device 18 and used in conjunction with the anatomicpositioning information obtained by processing the captured image todetermine the location for the virtual trace 62. The approximatelocation of the preferred vein and injection site is projected into thefield of view 100 (shown on FIG. 10) of the technician. The virtual veintrace 62 could be color-coded or animated to provide additionalinformation to the technician. For example, vein diameter informationcould be projected next to each virtual vein trace 62, to assist thetechnician in selecting a vein of an appropriate size and to assist inselecting an appropriately sized catheter. Similarly, veins of differentsizes could be displayed in different colors to assist in the selectionprocess.

Integrating data obtained by an imaging device, such as ultrasound,improves selectivity, accuracy, and specificity of the externalvisualization information projected to the technician. Accordingly, thetechnician can trust that the vein location being displayed is correctand is a vein suitable in size for the type of vascular access device 60being used.

The ultrasound image of vein anatomy can be saved locally on thewearable electronic device 18 or transmitted to an external data device,such as a patient database system, for inclusion in the patient'srecord. The ultrasound image could then be automatically provided forsubsequent vascular access treatments to assist in vein selection.

After the insertion is performed, the system 10 e may be configured toobtain a real-time ultrasound image to confirm correct placement of theneedle of the vascular access device 60 in the vein. Similarly, thesystem 10 e could record a time and date stamp for the insertion andinclude such information in the patient's record. The system 10 e mayalso record the location of the vascular insertion. This information maybe used to prevent repeat insertion in the same area of the patient'sbody.

In certain further embodiments, the ultrasound monitor 64 may beconfigured to provide real-time information to the technician. Forexample, the user interface 110 of the wearable electronic device 18 maybe configured to provide a real-time image obtained with the ultrasoundmonitor 64 to the technician's field of view 100. In this way, thetechnician could “watch” the insertion process to ensure that thevascular access device 60 is correctly inserted into the desired vein.Such real-time information allows the technician to correct for changesto anatomical structure and device location, which may occur during theinsertion process. Similarly, such a real-time system could be usefulfor assessing the viability, location, and changes in vein structure ofan indwelling vascular access device 60. Thus, the technician would bebetter able to determine when an indwelling vascular access device 60needs to be removed or repositioned.

In a further embodiment, the wearable electronic device 18 may includemeans for sub-dermal illumination by projecting light or radiation, suchas light provided by one or more LED bulbs or laser lightpipes onto thepatient's skin. The projected light may enhance visualization of theveins and could be used to improve the quality of the captured image.The enhanced captured image could be used to improve the approximatedvirtual trace 62 provided by the image processing functionality.Inter-cannula illumination or illumination with catheter stripes mayalso be used for increasing actual visualization of arteries and veinswithin the scope of the present invention.

The invasive device of the system may also be composed of a materialthat may be magnetized for use with ultrasonic systems that utilize amagnetic feature to enhance visualization and provide a means ofprojection in the form of a path as the invasive device moves toward thetargeted anatomy.

As in previously described systems 10 e, the user interface 110projected to the virtual layer 22 of the technician's field of view 100is beneficial for conveying important information about the procedure tobe performed, devices being used, and progress of the insertion processto the technician in a convenient and hands-free manner. With referenceto FIG. 8, the overall user visual experience of the system 10 eincludes having a virtual layer 22 projected over the technician's fieldof view 100 (shown in FIG. 10) that highlights the patient's vascularanatomy, giving the technician improved insertion success. FIG. 9 is aschematic representation of a virtual vein trace 62 covering a portionof a patient's arm.

With reference to FIG. 10, a further embodiment of the technician'sfield of view 100 including a virtual layer 22 projected over a realitylayer 24 is depicted. The virtual layer 22 includes a user interface 110consisting of a heading bar 112, which includes patient identifyinginformation and information about the procedure to be performed. Theuser interface 110 also includes an alert portion 124 that shows thetechnician when the needle of the vascular access device 60 is in thevein or when the needle has been transfixed, and the projectedtrajectory of the invasive device while it is being placed relative tothe targeted sub-dermal anatomy. The user interface 110 also includesone or more schematic images 126 showing the position of the needlerelative to the vein. For example, one schematic image 126A may show theposition of the needle relative to the vein from a top view, to show thetechnician whether the needle must be moved left or right, forward orbackward. The user interface 110 may also include a second schematicimage 126B depicting an elevation or side view, showing the depth of theneedle relative to the vein. It is further contemplated herein thatadditional schematic drawings depicting other images or views of thedesired structures may be provided for view in the user interface 110.For example, other views may include a cross-sectional view of theimages shown in first schematic image 126A or the second schematic image126B. Alternatively, an image taken out of the plane, such as an ultrasound probe, may also be provided. Finally, the user interface 110 mayinclude icons 128 showing certain information about the vascular accessdevice 60, such as the gauge or length of the catheter or needle.

In use, the technician begins by determining what procedure should beperformed and obtaining necessary equipment. As in previous embodimentsof the system 10 e, the technician may determine this information byscanning the patient ID 38. Based on the information obtained from thepatient ID 38, the user interface 110 may display instructions for theprocedure to be performed, instructions for what items must be obtained,and any other relevant information concerning the procedure or patient.The technician then obtains the items for the procedure, namely thevascular access device 60. The system 10 e may verify that the correctitems have been obtained by scanning an identification tag 30 for eachitem. An alert may display if the technician has failed to obtain aneeded item.

Prior to performing the injection or vascular access procedure, thetechnician may scan the desired insertion site with the wand 68 orscanner of the imaging device, such as the ultrasound monitor 64, toobtain a sub-dermal three-dimensional image of the patient'svasculature. The system 10 e may automatically process the obtainedimages and identify a suitable vein for insertion of the vascular accessdevice 60. While the vein is being identified, an image of the injectionsite is also obtained using the image capture functionality, such as thedigital camera 12 of the wearable electronic device 18. Processing thecaptured image identifies various anatomical markers, which are used todetermine the size, shape, and orientation of the patient's arm or otherchosen injection site. Based on these processing activities, a trace ofthe vein, referred to herein as the virtual vein trace 62, is shown tothe technician on the user interface 110. The technician positions theneedle of the vascular access device 60 based on the virtual trace 62.The technician then inserts the needle into the vein. The user interface110 may display an alert or confirmation when the needle is positionedcorrectly.

In addition to assisting in the positioning of the needle, the system 10e documents the insertion activities to confirm that the procedure wasin fact carried out correctly. For example, the time of the insertion,insertion location, name of the technician, insertion site, and otherinformation may be transmitted from the wearable electronic device 18 toa patient data system. The information is recorded to assist inperforming future insertion procedures.

While specific embodiments of the invention have been described indetail, it will be appreciated by those skilled in the art that variousmodifications and alternatives to those details could be developed inlight of the overall teachings of the disclosure. Accordingly, theparticular arrangements disclosed are meant to be illustrative only andnot limiting as to the scope of invention which is to be given the fullbreadth of the claims appended and any and all equivalents thereof.Further, although the invention has been described in detail for thepurpose of illustration based on what is currently considered to be themost practical and preferred embodiments, it is to be understood thatsuch detail is solely for that purpose and that the invention is notlimited to the disclosed embodiments, but, on the contrary, is intendedto cover modifications and equivalent arrangements that are within thespirit and scope of the appended claims. For example, it is to beunderstood that the present invention contemplates that, to the extentpossible, one or more features of any embodiment can be combined withone or more features of any other embodiment.

What is claimed is:
 1. A wearable electronic device comprising: ahousing; at least one visible light camera connected to the housing, theat least one visible light camera configured to acquire visible lightimages of a vascular access site of a patient; an augmented realitydisplay connected to the housing; and a controller configured to:receive at least one visible light image of the vascular access sitefrom the at least one visible light camera, the at least one visiblelight image comprising a plurality of blood vessels of the patient,process the at least one visible light image received from the at leastone visible light camera to identify a blood vessel for puncture fromthe plurality of blood vessels of the patient in the at least onevisible light image, wherein the identification of the blood vessel isbased on at least one of a position of an anatomical marker or anappearance of the vascular access site in the at least one visible lightimage, estimate a preferred size of an injection portion of a needlebased on a size of the identified blood vessel for puncture, report thepreferred size for the injection portion of a needle to a user via theaugmented reality display, display via the augmented reality displaywithin the user's field of view of the vascular access site a virtualtrace icon indicating a position of at least a portion of the identifiedblood vessel, wherein the virtual trace icon overlays the identifiedblood vessel, such that the user sees the virtual trace icon covering atleast the identified blood vessel and an actual view of portions of thevascular access site including a vascular access device, wherein theaugmented reality display is configured to project a virtual layercomprising the virtual trace icon within the user's field of view and auser interface, wherein the user interface comprises at least twoschematic images, wherein a first schematic image shows a position ofthe vascular access device from a first viewpoint and a second schematicimage shows the position of the vascular access device from a secondviewpoint, process at least one visible light image of the vascularaccess site from the at least one visible light camera including theneedle for insertion into the vein of the patient to determine a size ofthe needle, and provide an alert to the user of the wearable electronicdevice when the determined size of the needle differs from the estimatedpreferred size for the injection portion of the needle.
 2. The wearableelectronic device of claim 1, wherein the controller is configured toreceive and process the at least one image automatically, without aninput or actuation activity by the user.
 3. The wearable electronicdevice of claim 1, wherein the augmented reality display provides thevirtual trace icon to the user in a hands-free manner.
 4. The wearableelectronic device of claim 1, wherein the identification of the bloodvessel based on the position of the anatomical markers comprisesdetermining a location of at least two anatomical markers in the atleast one visible light image and estimating a location of a preferredblood vessel based on relative positioning of the at least twoanatomical markers.
 5. The wearable electronic device of claim 4,wherein the anatomical markers comprise one or more of the following:physical locations on the patient's body, including at least one of thewrist, fingers, thumb, elbow, shoulder, or any combination thereof, andexternally applied markers provided on the patient's skin or applied toa dressing.
 6. The wearable electronic device of claim 1, wherein thevirtual trace icon is color-coded to signify a preferred catheter gaugefor insertion.
 7. The wearable electronic device of claim 1, wherein thewearable electronic device is a head-worn computer, and wherein theaugmented reality display is a projection prism configured to projectthe virtual layer comprising the virtual trace icon within the user'sfield of view.
 8. The wearable electronic device of claim 7, wherein theuser interface further comprises at least one of a patient informationportion, a vascular access device information portion, or anycombination thereof.
 9. The wearable electronic device of claim 1,further comprising a radiation source connected to the housing, theradiation source being configured to generate a radiation beam which,when directed toward a portion of the patient's skin, increasesvisibility of the plurality of blood vessels visible through thepatient's skin.
 10. The wearable electronic device of claim 9, whereinthe radiation source comprises one or more of a light bulb, a lightemitting diode, a laser diode, and a laser light tube.
 11. The wearableelectronic device of claim 1, further comprising a peripheral data entrydevice that allows the user to manually enter data to the wearableelectronic device.
 12. The wearable electronic device of claim 11,wherein the peripheral data entry device comprises at least one of amotion sensor, a gyroscope, a pressure sensor, an accelerometer, atouchpad, a touchscreen, or any combination thereof.
 13. The wearableelectronic device of claim 1, further comprising a power supply withinthe housing of the wearable electronic device.
 14. The wearableelectronic device of claim 1, further comprising a wireless transmitterfor sending data to or receiving data from an external electronicdevice.
 15. The wearable electronic device of claim 14, furthercomprising a remote patient database, wherein the controller isconfigured to cause the wireless transmitter to send data to and receivedata from the patient database.
 16. The wearable electronic device ofclaim 15, wherein the information received by the wireless transmitterfrom the patient database includes information about an invasiveprocedure to be performed, information about the vascular access devicerequired for a particular procedure, or information about the patient.17. The wearable device of claim 1, wherein the controller is furtherconfigured to: process visible light images of the vascular access sitecaptured by the at least one visible light camera to detect anidentification tag attached to a blood sampling device used forobtaining a blood sample of the patient at the vascular access site, andextract a unique identification number of the blood sampling device usedto collect the blood sample by processing the identification tag. 18.The wearable device of claim 17, wherein, after the controller detectsthe identification tag in the captured images, the controller isconfigured to delay processing of the identification tag attached to thesampling device to extract the unique identification number until theidentification tag has been within the user's field of view for at leasta predetermined period of time.
 19. A system comprising: a wearableelectronic device configured to be worn by a user comprising a housingand an augmented reality display connected to the housing; one or morecameras connected to the housing configured to acquire visible lightimages of a vascular access site of a patient; an external sub-dermalscanner for providing images of sub-dermal structures in close proximityto the vascular access site, the images comprising a plurality of bloodvessels of the patient; and a controller configured to process one ormore images of sub-dermal structures obtained by the sub-dermal scannerto identify a blood vessel for a puncture procedure, estimate apreferred size for an injection portion of a needle based on a size ofthe identified blood vessel for puncture, report the preferred size ofthe injection portion of the needle to the user via the augmentedreality display, display via the augmented reality display within afield of view of the user of the vascular access site a virtual traceicon indicating a position of at least a portion of the identified bloodvessel, wherein the virtual vein trace icon overlays the identifiedblood vessel, such that the user sees the virtual trace icon covering atleast the identified blood vessel and an actual view of portions of thevascular access site including a vascular access device, process atleast one visible light image of the vascular access site from the oneof more cameras including the needle for insertion into the vein of thepatient to determine a size of the needle, and provide an alert to theuser of the wearable electronic device when the determined size of theneedle differs from the estimated preferred size for the injectionportion of the needle.
 20. The system of claim 19, wherein the externalsub-dermal scanner is connected to a monitor selected from one of thefollowing: an ultrasound monitor, an infrared monitor, a magneticresonance imaging monitor, or any combination thereof.
 21. The system ofclaim 19, wherein the controller is configured to process at least onevisible light image of the vascular access site captured by the one ormore cameras to estimate a position of the identified blood vessel andto position the virtual trace icon within the user's field of view basedon the estimated approximate position of the identified blood vessel,wherein the estimated approximate position of the blood vessel isdetermined based on at least one of a position of an anatomical markeror an external appearance of the vascular access site in the at leastone visible light image.
 22. The system of claim 19, wherein one or moreimages provided by the sub-dermal scanner are displayed to the user viathe augmented reality display of the wearable electronic device in realtime.
 23. The system of claim 19, wherein the one or more images ofsub-dermal structures are saved on a data storage medium of the wearableelectronic device or transmitted to an external data storage device viaa wireless transmitter of the wearable electronic device, and whereinsaved or transmitted images are accessible to determine a vascularaccess site for future vascular access procedures.
 24. The system ofclaim 19, further comprising a blood sampling device for obtaining ablood sample of the patient at the vascular access site and anidentification tag attached to the sampling device, wherein thecontroller is configured to: process images captured by the one or morecameras to detect the identification tag attached to the blood samplingdevice, and extract a unique identification number of the blood samplingdevice used to collect the blood sample by processing the identificationtag.
 25. The system of claim 24, wherein, after the controller detectsthe identification tag in the captured image of the vascular accesssite, the controller is configured to delay processing of theidentification tag attached to the sampling device to extract the uniqueidentification number until the identification tag has been within theuser's field of view for at least a predetermined period of time.
 26. Asystem for vein access confirmation, comprising: a wearable electronicdevice comprising: a housing; one or more cameras connected to thehousing configured to acquire visible light images of a vascular accesssite of a patient; a visual display for providing information to a user;and at least one microprocessor for managing and processing images fromthe one or more cameras; an external sub-dermal scanner for acquiringsub-dermal images of sub-dermal structures in proximity to a proposedvascular access site; a needle for insertion into a vein of the patientat the vascular access site; and a controller configured to: processsub-dermal images comprising a plurality of veins of the patientobtained by the sub-dermal scanner to identify a preferred vein of theplurality of veins for insertion of the needle, estimate a preferredsize for an injection portion of the needle based on a size of thepreferred vein, report the preferred size for the injection portion ofthe needle to the user via the visual display of the wearable electronicdevice, process at least one visible light image of the vascular accesssite from the one or more cameras, the visible light image including theneedle for insertion into the vein of the patient, to determine a sizeof the needle, and provide an alert to the user of the wearableelectronic device when the determined size of the needle differs fromthe estimated preferred size for the injection portion of the needle.27. The system of claim 26, further comprising at least oneidentification tag comprising information about the needle, wherein thecontroller is configured to process the at least one visible light imageto detect the at least one identification tag.
 28. The system of claim27, wherein the at least one identification tag comprises atwo-dimensional bar code, a three-dimensional bar code, a near fieldcommunication device, or a label having text readable by an opticalcharacter recognition algorithm.
 29. The system of claim 27, whereindetecting the at least one identification tag in the at least onevisible light image comprises identifying the identification tag in theat least one visible light image, delaying further processing of the atleast one image until the identification tag has been within a field ofview of the user for a predetermined period of time and, following thepredetermined period of time, extracting information about the size ofthe needle from the at least one identification tag.
 30. The system ofclaim 26, wherein the wearable electronic device is a head-worncomputer, and wherein the visual display comprises an augmented realitydisplay comprising a projection prism configured to project a virtuallayer to a field of view of the user.
 31. A method for insertion of aneedle into a vein assisted with a wearable electronic device forenhanced visualization, the method comprising: capturing images of apossible vascular access site with a visible light camera of thewearable electronic device, the wearable electronic device furthercomprising a microprocessor for processing images captured by thevisible light camera, wherein the captured image comprises the vascularaccess site and a plurality of veins of a patient; processing thecaptured images to identify a preferred vein of the plurality of veinsfor performing an injection at the vascular access site, wherein theidentification of the blood vessel is based on at least one of aposition of an anatomical marker or an external appearance of thevascular access site in the captured images; estimating a preferred sizefor an injection portion of a needle based on a size of the identifiedpreferred vein, reporting the preferred size of the injection portion ofthe needle to the user via the augmented reality display, displaying,via the augmented reality display and within the user's field of view ofthe vascular access site, a virtual vein trace icon indicating to theuser of the augmented reality display a position of at least a portionof the preferred vein, such that the user sees the virtual vein traceicon overlaying at least a portion of the preferred vein and an actualview of at least others of the plurality of veins in the user's field ofview and the needle for insertion into the vein, wherein the augmentedreality display is further configured to project a virtual layercomprising the virtual trace icon within the user's field of view and auser interface, wherein the user interface comprises at least twoschematic images, wherein a first schematic image shows a position ofthe vascular access device from a first viewpoint and a second schematicimage shows the position of the vascular access device from a secondviewpoint; processing captured images from the visible light cameraincluding the needle for insertion into the vein of the patient todetermine a size of the needle; and providing an alert to the user ofthe wearable electronic device when the determined size of the needlediffers from the estimated preferred size for the injection portion ofthe needle.
 32. The method of claim 31, wherein the wearable electronicdevice is a head-worn computer, and wherein the augmented realitydisplay comprises a projection prism configured to project the virtuallayer, including the virtual vein trace, to the user's field of view.